Operator II

Shelby American, Inc.; Minneapolis (MN); On-site; Full time

Job summary

An established industry player is seeking an Operator II to join their manufacturing team. In this role, you will be responsible for conducting general manufacturing operations, including product assembly and testing. Your attention to detail and ability to work in a fast-paced environment will be crucial as you ensure product quality and compliance with industry standards. This position offers a unique opportunity to contribute to the development of medical devices, making a tangible impact on patient care. Join a team that values innovation and quality, and enjoy a comprehensive benefits package that supports your health and well-being.

Benefits

Medical insurance

Dental insurance

Vision insurance

Paid Time Off (PTO)

Paid Holidays

401(k) Plan

Employee Life Insurance

Paid Parental Leave

Qualifications

• 3+ years of assembly/manufacturing experience in the medical device industry.
• Ability to read work orders and follow production drawings accurately.

Responsibilities

• Manufacture, inspect, and package products following written processes.
• Identify opportunities for productivity and quality improvements.

Skills

Assembly experience

Manufacturing experience

Attention to detail

Problem-solving skills

Ability to work under pressure

Education

High school graduate or GED equivalent

Job description

Description

Job Summary

The Operator II role will be responsible for conducting general manufacturing operations, testing of product, assembly of product, and product development activities. Individuals will utilize manufacturing and testing procedures in the manufacturing of product.

Essential Functions

1. Manufacture, inspect, and package products following written processes
2. Read work orders, follow production drawings, and complete necessary documents
3. Perform routine assignments according to specified and/or standardized procedures
4. Communicate progress and report problems to Line Lead or Supervisor
5. Identify opportunities for productivity and quality improvements
6. Train other team members on an as needed basis
7. Ensure equipment is maintained and calibrated within defined timelines to minimize interruption to production lines
8. Maintain a clean, safe, and organized work environment
9. Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.

Requirements

Education, Experience, Required Skills

1. High school graduate or GED equivalent
2. 3+ years of assembly and/or manufacturing experience in the medical device industry
3. Accurately read work orders, follow production drawings, and receive instruction
4. Accurately complete all essential documents (Lab Notebooks, Device Master Records, Lot History Records, Inspection Records, and Validation Documentation)
5. Hand dexterity, including ability to work with very small pieces (some under microscope and some not) – requires patience and diligence
6. Ability to handle and be trusted with confidential and/or sensitive information.
7. Able to work in a fast-paced, constantly changing environment.
8. Ability to be flexible and to handle multiple projects in an organized, timely manner.
9. Able to problem-solve, work under pressure, and to effectively manage stress.
10. Ability to work overtime as needed

Physical Requirements

1. Prolonged periods of sitting at a desk and working on a computer and/or microscope.
2. Prolonged periods of standing and/or walking.
3. Must be able to lift up to 25 pounds at times.
4. Manual dexterity in order to assemble products or machines as directed
5. Excellent hand-eye coordination
6. Ability to differentiate between colored wires, tabs, and electronic components
7. Must wear gown, gloves, and ear protection when applicable
8. Must be willing to work in lab and clean room environments to support project work

Summary of Benefits

1. Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
2. Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
3. Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
4. Accrued Paid Time Off (PTO) & Floating Holidays
5. Paid Parental Leave
6. Paid Holidays
7. Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

1. The typical base pay range for this role is between $19.00-23.00/hour. Compensation may vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
2. 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.